ABSTRACT:
The purpose of this work was to develop and validate a new ion-pair reversed phase high performance liquid chromatographic method on a standard C18-type stationary phase with UV detection, for the analysis of the two antihyperlipidemic agents as a combination in tablets atorvastatin-ezetimibe. The mobile phase consisted of a 35% of cetyltrimethylammonium bromide (cetrimide) 10-3 M as the ion-pairing agent and 65% acetonitrile. The pH value of the mobile phase was adjusted if necessarily by ammonia solution at 10. The flow rate was 1.5 mL/min and the separation was performed at 40º. The method validation was based on linearity, accuracy, precision and specificity. This method exhibited good linearity and accuracy with mean recovery values between 95-105%, precision with relative standard deviations of the calculated concentrations less than 2% and specificity in the presence of excipients. These results indicates that the proposed method is applicable for the separation and determination of atorvastatin-ezetimibe combination in tablets and could be a relevant method to utilize in quality control laboratories.
Cite this article:
Saleh Trefi. Simultaneous assessment of Atorvastatin-ezetimibe combination in tablets by An Ion-pair RP-HPLC. Research J. Pharm. and Tech 2020; 13(9):4195-4199. doi: 10.5958/0974-360X.2020.00741.6
Cite(Electronic):
Saleh Trefi. Simultaneous assessment of Atorvastatin-ezetimibe combination in tablets by An Ion-pair RP-HPLC. Research J. Pharm. and Tech 2020; 13(9):4195-4199. doi: 10.5958/0974-360X.2020.00741.6 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-9-29
REFERENCES:
1. Block J H, Beale J M. Wilson, Gisvold's. textbook of organic medicinal and pharmaceutical chemistry.11th ed. Philadelphia: Lippincott Williams and Wilkins. 2004;622-75.
2. Ozbag D, Gumusalan Y, Kilinc M, Toru I, Ciralik H. Effect of atorvastatin and ezetimibe treatment on serum lipid profile and oxidative state in rats fed with a high-cholesterol diet. The American journal of the medical sciences. 2010; 339(5): 448-452.
3. Kavita W, Sandeep S, Santosh C, Sanjay K. Development of a RP-HPLC method for separation of ezetimibe in presence of atorvastatin calcium and simvastatin and its application for quantitation of tablet dosage forms. Asian journal of pharmaceutical analysis. (2017) 7(3). 169-175.
4. Sahu P K, Murthy Pyla S R, Srinivas K, Swain S. Simultaneous RP-HPLC method development and validation of atorvastatin, ezetimibe and fenofibrate. Pharmaceutical Regulatory Affairs. 2016; 5(2): 139-156.
5. Sree Janardhanan V, Manavalan R, Valliappan K. Chemometric technique for the optimization of chromatographic system: simultaneous HPLC determination of rosuvastatin, telmisartan, ezetimibe and atorvastatin used in combined cardiovascular therapy. Arabian journal of chemistry. 2016; 9(2): s1378-s1387.
6. Raul K S, Aravelli B A, Jhansi D. RP-HPLC method development and validation of for the simultaneous estimation of atorvastatin and ezetimibe in pharmaceutical dosage form. Asian journal of pharmaceutical and clinical research. (2015); 8(2): 178-181.
7. Ashutosh Kumar S, Manidipa D, Seshagiri Rao JVLN. New validated RP-HPLC analytical method for simultaneous estimation of atorvastatin and ezetimibe in bulk samples as well in tablet dosage forms by using PDA detector. Current Drug Discovery Technologies. 2014; 11(4): 9-15.
8. Kasimala B B, Anna V R, Mallu U R. Development and validation of an RP-HPLC method for the simultaneous estimation of atorvastatin and ezetimibe in pharmaceutical dosage forms. Journal of atoms and molecules. (2014); 4(3): 758-768.
9. Dhiware AD, Deshpande PB, Gandhi SV, Nair S, Vanjari S. A simple and sensitive RP-HPLC method for the simultaneous estimation of atorvastatin calcium, ezetimibe and fenofibrate in combined tablet dosage form. Research journal of pharmacy and technology. (2013) 6(10). 1085-1088.
10. Ganesh M, Hemalatha P, Sakthimanigandan K, Mei P M, Lee S G. Simultaneous estimation of atorvastatin and ezetimibe in combined formulation by RP-HPLC. Asian journal of chemistry. (2012); 24(4): 1867-1871.
11. Alshehri M M. A validated capillary electrophoresis method for simultaneous determination of ezetimibe and atorvastatin in pharmaceutical formulations. Saudi pharmaceutical journal. (2012); 20(2): 143-148.
12. Nagaraju P, Vishnu Vardhan Z, Seshagiri Rao JVLN. A validated reverse phase HPLC method for the simultaneous estimation of atorvastatin calcium and ezetimibe in pharmaceutical dosage forms. Asian journal of research in chemistry. (2010) 3(1). 225-228.
13. Mundlik MB, Gadewar CK, Chandekar NA, Mahajan NM, Telgote PD, Chandewar AV. RP-HPLC method for simultaneous estimation of atorvastatin calcium ezetimibe in pharmaceutical formulation. Asian journal of research in chemistry. (2010) 3(2). 485-490.
14. Titus JFM, Thenmozhi A, Sridharan D. An ion-pair chromatography method for simultaneous estimation of tramadol and paracetamol in combined tablet dosage form. Research journal of pharmacy and technology. (2010); 3(1): 179-182.
15. Seshachalam U, Kothapally C B. HPLC analysis for simultaneous determination of atorvastatin and ezetimibe in pharmaceutical formulations. Journal of liquid chromatography and related technologies. (2008); 31(5): 714-721.
16. Neelima B, Ravikumar P, Muralikrishna M, Hima Bindu V, Prasad Rajendra Y. Simultaneous determination of atorvastatin and ezetimibe by RP-HPLC in pure and pharmaceutical dosage form. Int. J. Chem. Sci. (2008); 6(3): 1576-1582.
17. Qutab S S, Razzaq S N, Khan I U. Simultaneous determination of atorvastatin calcium and ezetimibe in pharmaceutical formulations by liquid chromatography. Journal of food and drug analysis (2007); 15(2): 139-144.
18. Trefi S. Assay of four psychotropic drugs chlorpromazine, clomipramine, amitriptyline and nortriptyline in tablets by a single HPLC method. International Journal of Pharmacy and Pharmaceutical Sciences (2016); 8(8): 182-188.
19. Shasho H, Alhaj sakur A, Trefi S, separation and assay of four antihistamine drugs diphenhydramine, chlorpheniramine, cyproheptadine and fexofenadine in pharmaceuticalforms by a single HPLC method, International Journal of Pharmacy and Pharmaceutical Sciences. 2018; 4(10):53-60.
20. Trefi S, Bitar Y. Separation and analysis of amlodipine / benazepril combination in capsules by a novel ion pair liquid chromatography. International Journal of Pharmacy and Pharmaceutical Sciences (2019); 11(1): 107-112.
21. Trefi S, Bitar Y, Gilard V. Separation and quantification of sacubitril-valsartan combination in tablets by a new ion-pair HPLC. Research journal of pharmacy and technology. (2019); 12(3). 1017-1022.
22. Hammash L, Bitar Y, Trefi S. Novel ion-pair HPLC methods for the assessment of sitagliptin and pioglitazone in tablets. Research journal of pharmacy and technology. (2019) 12(8).
23. Guideline.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf).